Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00045786
First received: September 9, 2002
Last updated: June 23, 2005
Last verified: May 2004
  Purpose

The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: CC-1088
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 39
Study Start Date: October 2001
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
  • Patient must be able to adhere to the study visit schedule and other protocol requirements.
  • Patient must understand and voluntarily sign an informed consent document.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
  • Women must not be pregnant or lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045786

Locations
United States, Illinois
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States, 60612-3515
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00045786     History of Changes
Other Study ID Numbers: CC-1088-MDS-801-001
Study First Received: September 9, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
myelodysplastic syndrome

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014